MAUDE Adverse Event Report: LDR MÉDICAL ROI-C IMPLANT 12X14 H6; LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3004788213-2021-00030 to 3004788213-2021-00032.
Event or Problem Description
It was reported that during surgery the plates could not be completely inserted into the cage.The surgeon had difficulty removing the plates and the cage and all three items were damaged during removal.A new cage and plates were used to complete the surgery without impact on the patient.This is report one of three for this event.
Event or Problem Description
It was reported that during surgery the plates could not be completely inserted into the cage.The surgeon had difficulty removing the plates and the cage and all three items were damaged during removal.A new cage and plates were used to complete the surgery without impact on the patient.This is report one of three for this event.
Additional Manufacturer Narrative
Added information to h6: component codes, type of investigation, investigation findings, investigation conclusions.This follow-up report is being submitted to relay additional information and initially corrected information.Summary: the complaint is confirmed for one (1) of one (1) returned roi-c implant 12x14 h6mm (pn: mc1342p) for the failure of cage fractured.Visual inspection revealed the cage is fractured and one of the anchoring plates has deformation damage on both ends of the device.Medical records were not provided for review.Potential cause: the cause of the damage cannot be determined at this time since there is no information available regarding how the screw inserter was being used or handled at the time of the damage.Dhr review and related actions: per dhrs review, the parts were likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use: this devices are used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: ROI-C IMPLANT 12X14 H6
• Common Device Name: LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• MDR Report Key: 11496827
• Report Number: 3004788213-2021-00030
• Device Sequence Number: 4497555
• Product Code: ODP
• UDI-Device Identifier: 03662663016285
• UDI-Public: (01)03662663016285(17)241101(10)75253
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2024
• Device Model Number: N/A
• Device Catalogue Number: MC1342P
• Device Lot Number: 75253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/20/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 69